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The objective of this study is to compare side-by-side ALLOD-2 to sumatriptan, (a current acute migraine standard of care treatment), in the acute treatment of migraine.

The investigational product (ALLOD-2), is a combination of two marketed drugs used for the acute treatment of migraine due to the discovery of biologically and clinically relevant affinities for a new target for pain. Both drugs are used at a significantly lower dosage compared to the dosage that has already been approved for the marketed indications.

The combination is a First-in-Class drug due to its new and unique mechanism of action.

The investigators propose that in predisposed individuals, migraine attacks occur due to exuberant innate immune system activation nearby the trigeminal nerve and other cranial nerves. The innate immunity activation leads to the release of pro-inflammatory cytokines [nitric oxide (NO), tumor necrosis factor-α (TNF-α), and reactive oxygen species (ROS)], and to the activation of cyclooxygenase-2 (COX-2), which produces neuro-inflammation, causing headache and various migraine-associated symptoms.

The investigation will focus on the comparison of migraine-associated nausea, which has been shown none-responsive to other known migraine treatments and is considered an unmet treatment need.

ALLOD-2 reverses the neuro-inflammation through dual action, inhibition of the release of pro-inflammatory cytokines and inhibition of the activation of COX-2. Efficacy of this product for migraine headache pain and for migraine-associated symptoms, especially nausea, may suggest the product addresses the root cause of migraine.

The study consists of a screening visit, at home treatment of a migraine attack with a single dose of the study drug within 8 weeks, and End-of-Study Visit 2-7 days after the treatment of a moderate or severe migraine attack. The duration of patients' participation in the study is up to 9 weeks.

Single Site, Phase 2B, Randomized, Double-Blind, and Placebo-Controlled Study to Assess the Efficacy and Safety of a Single Dose of ALLOD-2 Versus Sumatriptan in the Acute Treatment of Migraine With Associated Nausea in Adults (ANODYNE-2)

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female 18 to 65 years of age.

History of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version) for at least one-year with first migraine prior to age 50.

Migraine-associated nausea with ≥half the migraine attacks.

2 - 8 migraines per month in each of the previous 3 months.

The patient is able to complete study questionnaires, comply with the study requirements and restrictions, and willing to provide written informed consent and authorize HIPAA.

The female patient who is premenopausal or postmenopausal less than 1 year, or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative urine pregnancy test, be non-lactating, and commit to using 2 methods of adequate and reliable contraception throughout the study and for 28 days after taking the last dose of the study drug (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). Male patients must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after the study.ice, hormonal contraception).

Exclusion Criteria:

The patient in the opinion of the investigator may have medication-overuse headaches (as defined by ICHD - 3 beta criteria for medication-overuse headache) during the preceding 3 months.

The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine) during the preceding 3 months.

Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.

The patient has a history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol.

The Female patient is pregnant or breast-feeding. The Male patient is not practicing 2 different methods of birth control with their partner during the study, and for 28 days after the investigational drug last dose or will not remain abstinent during the study, and for 28 days after the last dose.

The patient has known-hypersensitivity reaction to any of the components of the investigational drug.

Consumption of analgesic medication or muscle relaxants (including all benzodiazepines) for other conditions on a regular basis.

The patient has used emergency care treatment more than 3 times in the previous 6 months.

The patient has participated in another study with an investigational drug within 30 days prior to randomization and/or plan to participate during the study.